The companies leading the charge for medical devices

Innovation and medical plastic devices go hand in hand. Lu Rahman selects some of the stand-out companies that are taking the sector to the next level.

It’s no secret that the medtech sector innovates with the best of them. As medical devices increase in functionality, as healthcare professionals demand more from medical products and as patients expect better usability and comfort, innovation does have to step up to the mark offering the above in a cost-effective, long-lasting design.

Innovating successfully requires knowledge. With expertise in the medical plastics sector, Clariant understands the role that innovation plays alongside product development. But device developers face a double challenge, the company’s Stephen Duckworth told MPN, in that they need to, “develop products that are functional, compliant and easy to manage for medical professionals in clinical settings, but they also need to keep consumers/patients in mind.”

He added: “These users select and rely on these products to monitor health status, manage chronic conditions, and dispense medications at home, in the workplace, or on the go, and they want devices that are attractive and easy to use.”

Creating these type of products requires in-depth knowledge. Companies such as Clariant boast detailed knowledge of regulations plus an awareness of the need for materials to meet critical performance properties and at the same time meeting biocompatibility and toxicity standards.

Beyond material selection and suitability, market knowledge – initiatives and programs that will affect the on-going life of the product – is key. Product identification and anti-counterfeiting are becoming increasingly important. Aware of this, Clariant recently teamed up with SICPA, a trusted provider of global security solutions. The two companies have launched the Plastiward system, which uses proprietary covert taggant additives (produced by SICPA) that are compounded into various polymers at one of Clariant’s ISO13485-certified plants. The taggants then become an integral part of the plastic product or packaging and are readily detectable using SICPA’s proven deployment and monitoring platform. Once the tagged product enters the supply stream, the SICPA monitoring system is able to identify them at any point from factory to pharmacy.

Faking it

Product counterfeiting is serious. Netstal has been looking at the problem and says it has devised a reliable and inexpensive solution with its partners. It recognises that counterfeit products pose a threat to people and to a company’s brand image.

To overcome this problem, Dr Patrick Blessing, head of Netstal's Medical Technology and Precision Parts business unit told MPN that by “using smart tools, it is possible to add both visible and invisible markings to products during the injection moulding process”.

Special devices can electronically detect markings invisible to the human eye – easily and inexpensively, said Netstal. For example, thanks to an integrated testing process, a laboratory machine can determine whether it has been stocked with original consumable materials or not. This also helps the work of customs agents to quickly identify counterfeit products.

Stess test

On-going material research helps advance the medical plastics sector. Last year Sabic’s and PDI announced the results of a joint study on the environmental stress cracking resistance (ESCR) of Sabic’s materials used for medical device enclosures.

The two companies evaluated how well Sabic’s thermoplastics withstand repeated exposure to PDI’s Super Sani-Cloth wipes, a surface disinfectant used in healthcare to prevent healthcare-associated infections (HAIs). The study revealed that several of Sabic’s product technologies – including LEXAN EXL polycarbonate (PC) resin, XYLEX (PC/polyester blend) resin and VALOX polybutylene terephthalate (PBT) resin – deliver improved compatibility with PDI’s leading hospital-grade disinfectant.

Studies such as this are important for innovation to continue. “Sabic and PDI are committed to supporting the healthcare industry with information about compatibility between medical enclosure materials and commonly used disinfectants. Our joint study highlights the complex issue of environmental stress cracking, and provides valuable insights to help our customers make informed material selection decisions,” said Cathleen Hess, healthcare business leader for Sabic.

Press print

The medical device sector watches closely the on-going research that helps drive the industry. Researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have made the first entirely 3D-printed organ-on-a-chip with integrated sensing. 

Built by a fully automated, digital manufacturing procedure, the 3D-printed heart-on-a-chip can be fabricated with customisable size, shape and other physical properties, allowing researchers reliable date to be easily collected for short-term and long-term studies.

This type of device offers potential for healthcare and may one day allow researchers to rapidly design organs-on-chips, also known as microphysiological systems, that match the properties of a specific disease or even an individual patient's cells.

"Our microfabrication approach opens new avenues for in vitro tissue engineering, toxicology and drug screening research," said Kit Parker, professor of bioengineering and applied physics at SEAS.

Get your coat

Many companies are continually looking at ways to improve the performance of medical devices. Jeff Hendricks Biotectix, explained how polymeric coatings can help do just that.

Hendricks notes that one of the primary challenges facing next-generation cardiac and neuromodulation devices is electrode miniaturisation. Smaller electrodes are desirable to communicate with single neurons or small groups of cells, and to provide highly targeted stimulation in procedures such as deep brain stimulation, for example, while avoiding the side effects of collateral stimulation. However, as the electrode size decreases its ability to transport charge also declines, leading to high interfacial impedance.

Conducting polymers are an excellent material choice for miniaturised electrodes because they can safely deliver the necessary charge without damaging the tissue for stimulation and reduce noise for higher quality recording.

Biotectix’s conducting polymer coatings offer the possibility to improve the safety and performance of existing medical devices and to enable electrode and device size reductions by reducing impedance. These materials can also be used to create custom textile-based electrodes for consumer wearable and medical monitoring devices. Furthermore, they can help reduce device cost, reduce device size, and have the potential to open up new capabilities for medical and consumer electronic devices.

Take the tube

It’s always good to hear about the development of new devices. Cambridge Design Partnership (CDP) teamed up with King’s College London to develop a novel steerable catheter designed by King’s researchers. The catheter aims to improve the treatment of cardiac arrhythmia – a range of conditions which can lead to stroke or heart failure that affects 2 million people a year in the UK.The new steerable, micro-moulded catheter enables targeted delivery of radio frequency energy to specific points in the heart tissue for corrective treatment. Compared with traditional catheters, the device has been designed to be quicker and easier to manoeuvre into the correct position, improving the accuracy of positioning and minimising damage to healthy tissue, which should improve success rates of the treatment. 

Matt Brady, head of medical therapy, Cambridge Design Partnership, said: “The steerable catheter is an extraordinary product, with innovative features that enable corrective treatment to be delivered to very specific areas of the heart. By enabling greater accuracy and quicker treatment time, we believe it is possible to preserve more healthy heart tissue, and increase the success of the treatment. It’s been hugely exciting to be involved in this joint project with King’s College London and use our expertise to bring such an innovative product one step closer to commercial use.”

Qosina reveals its innovative year

For a business to be profitable or even survive, it has to be innovative. A company must keep up with technology, meet market requirements and implement more effective and efficient processes and services, while catering to customers’ needs. Qosina Corp, a global supplier of stock OEM components to the medical and pharmaceutical industries, recently made significant upgrades that it says will boost product lines, inventory operations and delivery solutions, as well as reducing its environmental footprint.

New enteral connectors

To improve patient safety, Qosina added a number of ENFit products to its inventory. This line of enteral feeding connectors meet the ISO 80369-3 standard, which has been developed by the International Organisation for Standardisation to reduce the risk of small-bore misconnections used in liquid and gas healthcare applications.

ISO certification

Because quality and safety are non-negotiable in the world of medical components, Qosina has gained ISO 13485 certification. This globally recognised standard specifies the requirements for a quality management system that can be used by organisations providing medical devices, components and delivery of related services. The company is also ISO 9001 and ISO 14001 certified.

Larger facility

Qosina recently moved its operations to a 95,000 square-foot, climate-controlled facility with an ISO Class 8 cleanroom. The new building provides the infrastructure to house its medical components, and store inventory for just-in-time delivery to its customers.

Paperless office system

Last year Qosina became a paperless office. This not only reduced its environmental footprint and improved operational efficiencies but it also freed up storage space, allowing for better inventory management solutions for customers and providing just-in-time delivery to meet specific production capacity.